A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
| Registry | NCT00990093 |
|---|
| Status | Completed |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, crossover, masking: none, treatment |
|---|
| Enrollment | 36 (Actual) |
|---|
| Sponsor | Coloplast A/S (Industry) |
|---|
| Conditions | Spinal Cord Injuries |
|---|
| Interventions | test intermittent catheter, Intermittent catheterization (Device) |
|---|
| Dates | start 2009-11-01, primary completion 2010-03-01, completion 2010-03-01, first posted 2009-10-06, last updated 2012-09-05 |
|---|
| Locations | 1 site in Denmark |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Spinal Cord Injuries All trials of test intermittent catheter All trials of Intermittent catheterization
-Summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
Expand all sections · Collapse all
+Detailed description
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| test intermittent catheter | Experimental | Device: test intermittent catheter | CH 12 hydrophilic coated catheter |
| intermittent catheter | Experimental | Device: Intermittent catheterization | CH 12 hydrophilic coated catheter |
- test intermittent catheter (Device), also known as Test catheter: CH 12 hydrophilic coated catheter
- Intermittent catheterization (Device), also known as SpeediCath: CH 12 hydrophilic catheter
+Outcome measures
Primary outcomes
- Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. [14 days]: Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
+Eligibility
Sex: Male, ages: 18 Years to any
Inclusion Criteria:
* At least 18 years of age
* Has normal/impaired sensation in the urethra
* Self-catheterises at least 4 times per day
* Has used clean self-intermittent catheterisation for at least 14 days
* Is able to open and prepare the catheters for catheterisation
* Has signed the informed consent before any study related-activities.
Exclusion Criteria:
* Has a symptomatic urinary tract infection as assessed by the investigator
* Is mentally unstable as assessed by the investigator
+Posted results
Participant flow
| Milestone | A: First Test Catheter Then Standard Catheter | B: First Standard Catheter Then Test Catheter |
|---|
| Started | 19 | 17 |
| Completed | 15 | 15 |
| Not completed | 4 | 2 |
Outcome results
- Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. (Primary), Mean, units on a scale: Test Catheter 1.59 +/- 2.28; Standard Catheter 1.94 +/- 2.24
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Test Catheter | 0 | 0/32 (0.0%) | 1/32 (3.1%) |
| Standard Catheter | 0 | 0/34 (0.0%) | 1/34 (2.9%) |
Other adverse events by term
| Term | Organ system | Test Catheter | Standard Catheter |
|---|
| epididymitis | Infections and infestations | 0/32 | 1/34 |
| discomfort during insertion | Renal and urinary disorders | 1/32 | 0/34 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Klinik for Rygmarvsskader | Hornbæk | Denmark | |
+Publications
- Results publication: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5. PMID 34699062
- Results publication: Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22. PMID 21339763
+Investigators
- Fin Biering-Sørensen, MD, Principal investigator, Klinik for Rygmarvsskader, Rigshospitalet